Effects of Peginterferon Consolidation Therapy on Hepatic cccDNA Dynamics in CHB Patients Achieving Clinical Cure.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Peginterferon α-2b based injection.
- Who it may be relevant to
- Registry conditions: Chronic Hepatitis b. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
An Exploratory Clinical Study Evaluating the Impact of Interferon Consolidation Therapy on Intrahepatic cccDNA Levels in Chronic Hepatitis B Patients Who Achieved Clinical Cure With Peginterferon α-2b Therapy.
Overview
This is a single-center, prospective, exploratory clinical study. The study plans to enroll 30 chronic hepatitis B (CHB) patients which achieved HBsAg clearance based peginterferon α-2b treatment. Eligible subjects will receive either 12-24 weeks interferon consolidation therapy (180μg administered subcutaneously in the abdomen or thigh once weekly) or not according to physician's recommendation and patient's preference, with regular follow-up for HBV recurrence. Patients will be followed up every 12 weeks. The study will evaluate changes in intrahepatic covalently closed circular DNA (cccDNA) and peripheral blood HBV pregenomic RNA (pgRNA) levels after achieving HBsAg clearance.
Interventions
- Drug Peginterferon α-2b based injection
Peginterferon α-2b injection, 180 μg administered subcutaneously in the abdomen or thigh once weekly, with regular follow-up for HBV recurrence. Patients will be followed up every 12 weeks.
Primary outcome measures
- Changes in intrahepatic cccDNA and peripheral blood pgRNA levels [Time frame: baseline to week48]
- Clearance rate of intrahepatic cccDNA [Time frame: week48]
Secondary outcome measures (9)
- Correlation between changes in intrahepatic cccDNA levels and interferon consolidation therapy [Time frame: baseline to week48]
- Correlation between changes in peripheral blood pgRNA levels and interferon consolidation therapy [Time frame: baseline to week48]
- Correlation between intrahepatic cccDNA clearance and interferon consolidation therapy [Time frame: week48]
- Changes in intrahepatic cccDNA levels [Time frame: baseline to week48]
- Changes in intrahepatic HBsAg levels [Time frame: baseline to week48]
- intrahepatic HBsAg clearance rate [Time frame: baseline、week48]
- Histopathological scores in hepatic inflammation and fibrosis [Time frame: baseline、week48]
- Recurrence rate [Time frame: baseline to week48]
- Adverse Event#AE# [Time frame: baseline to week48]
Eligibility criteria
Inclusion criteria
- Voluntarily enroll in the study, able to understand and voluntarily sign the informed consent form;
- Aged 18-65 years (inclusive), no gender restriction;
- A history of HBsAg positivity for at least 6 months or other evidence suggesting chronic hepatitis B;
- First observed clinical cure after treatment with peginterferon α-2b (PegIntron®), either as monotherapy or in combination with NAs, defined as serum HBsAg negative (<0.05IU/ml), HBV DNA undetectable (HBV DNA<20IU/ml), and HBeAg negative, within a 4-week window from the first observed day of clinical cure at the time of screening;
- Agreement to undergo two liver biopsies during the study;
- Negative pregnancy test within 24 hours before the first liver biopsy (for childbearing-age females); and subjects (both male and female) should use effective contraception during the study period.
Exclusion criteria
- Lactating women;
- Evidence of acute severe liver injury: such as ALT > 10 ULN, or significantly elevated ALT with significantly elevated bilirubin;
- Evidence of decompensated liver disease: such as ascites, esophageal varices rupture bleeding, sepsis, hepatic encephalopathy, hepatorenal syndrome, etc.; or history of decompensated cirrhosis;
- Evidence of hepatocellular carcinoma;
- Prothrombin time (PT) or INR > ULN;
- Participation in other interventional trial studies within 3 months before screening or other conditions deemed unsuitable for inclusion by the investigator.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Xiamen Hospital of Traditional Chinese Medicine — Xiamen
Identifiers
NCT: NCT06920329 · 2024K04701